Mhairi Strachan’s Post

More than 30 years ago, Bispecific T-cell Engager (BiTE®) technology was developed with the goal of finding new ways to help people facing the toughest-to-treat cancers. These efforts came to fruition nearly a decade ago, when Amgen's novel immunotherapy became the first globally approved BiTE® molecule, expanding options for people with advanced B-cell lineage acute lymphoblastic leukemia (B-ALL), a patient population with historically dismal outcomes and limited treatment options. Over the past ten years, it’s been inspiring to see our T-cell engager impact relapsed or refractory and measurable residual disease (MRD)-positive B-ALL patients. Now with @FDA approval for Ph-negative B-ALL patients regardless of their MRD status, Amgen is again poised to transform possibilities for people with this aggressive blood cancer. Read more👇#MyCompany

📢 FDA Grant Accelerated Approval to CAR-T Breyanzi in 3L r/r Follicular Lymphoma (Juno Therapeutics, Inc.) ➤ AA based on ORR from Phase 2, single-arm TRANSCEND-FL (NCT04245839) in adults with relapsed or refractory FL after two or more lines of systemic therapy. ➤ Remarkably, ORR was 95.7% (95% CI: 89.5, 98.8). After a median follow up of 16.8 months, median DOR was not reached (95% CI: 18.04, NR). ➤ Most common nonlaboratory adverse reactions (≥20%) were cytokine release syndrome, headache, musculoskeletal pain, fatigue, constipation, and fever. #oncology #biotech #biotechnology #regulatoryaffairs #pharma #drugdevelopment #oncologytrials #oncologyresearch #cancer #oncology #regulatoryintelligence #regulatoryprecedent https://lnkd.in/eQUd_t2h

Despite significant advances over recent years, the treatment of T cell acute lymphoblastic leukemia (T-ALL) remains challenging. We have recently shown that a subset of T-ALL cases exhibited constitutive activation of the lymphocyte-specific protein tyrosine kinase (LCK) and were consequently responsive to treatments with LCK inhibitors and degraders such as dasatinib and dasatinib-based #PROTACs. Here we report the design, synthesis and in vitro/vivo evaluation of #SJ45566, a potent and orally bioavailable LCK #PROTAC. #Protac #PDC #SmallMolecule #Medchem #Medcinal #FFS #FTE #CDMO #CMC

Venetoclax Combined with Intensive Chemotherapy: A New Hope for Refractory and/or Relapsed Acute Myeloid Leukemia? Authors: Ramy Rahmé & Thorsten Braun I am happy to share with you our latest opinion article/review on the treatment of refractory/relapsed acute myeloid leukemia with intensive chemotherapy approaches. In particular, we focus on chemotherapeutic regimens incorporating the BCL2 inhibitor venetoclax. Available data are indeed scarce on this matter. Still, they show higher rates of complete remission than historical reports, bridging a substantial number of patients to allogeneic transplant with the potential of cure. Website:

Novartis' Scemblix Excels in Phase III Trial, Significantly Outperforming Standard-of-Care TKIs in Newly Diagnosed CML Patients https://lnkd.in/dd2ndZrg #Pharma #pharmaceutical #healthcare #globalhealth #Patientcare #news #media #medicine #digitalhealth #PublicHealth #ASCO #ESMO #Cancer #oncology #cancer #cancerresearch #cancertreatment #cancercare #cancerawareness #cancersurvivor #cancertherapy #cancerpatients

Over the last decades, outcomes in B-cell acute lymphoblastic leukemia (B-ALL) have improved enormously thanks to developments in treatment. However, drug resistance and relapse, particularly among adults patients, is still a big challenge. This issue of Haematologica reports on a new potential therapeutic target for B-ALL: the mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1). https://lnkd.in/d8t4pABj

Have we improved outcomes of Acute Leukemia ? An important milestone was achieved in #precisionmedicine for Acute Leukemia with positive results of Menin Inhibitor Syndax Pharma announced the results of the pivotal AUGMENT-101 trial of revumenib in R/R adult and pediatric patients with KMT2Ar #acuteleukemia. Key takeaways: ✅ Met primary endpoint - CR/CRh rate: 23% (13/57; 95% CI: [12.7, 35.8, one-sided p-value = 0.0036])  🏥 Differentiation syndrome - a way at which leukemia cells differentiate to more mature adult cells leading to toxicity was noted, a side effect seen with many drugs e.g. ATRA used in Acute Pre-myeloid leukemia. Keep an eye out on the severity of this during ASH2023 💊 This would an important step in innovation and advancement in this hard-to-treate acute leukemia. Excited to learn more about the trial and other Menin inhibitors in development at #ASH23 in December #Innovation #DrugDevelopment

KOMET-007 is actively recruiting patients with newly diagnosed or relapsed/refractory NPM1-mutant or KMT2A-rearranged acute myeloid leukemia. KOMET-007 is a Phase 1 study to assess the safety, tolerability, and preliminary clinical activity of ziftomenib in combination with venetoclax+/-azacitadine, or standard induction cytarabine/daunorubicin (7+3) chemotherapy. To find out more about this trial and the KOMET clinical trial program, visit https://lnkd.in/eUriz4NM

Eli Lilly and Company announced that the U.S. FDA approved Jaypirca® (Pirtobrutinib) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton's tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor. Jaypirca (Pirtobrutinib) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent (reversible) inhibitor of the enzyme BTK. Chemenu has been working to develop more compounds for drug discovery. Here come the building blocks we can provide:  https://lnkd.in/gygEwiB8 #Pirtobrutinib #Jaypirca #CLL #SLL #BTK #BCL-2 #Chemenu #buildingblocks

If you're interested in attending a webinar on 05/07 that showcases how the Operetta CLS was used to test drug sensitivity in leukemia cells, click on the following link: https://lnkd.in/gzaWj4iB. #highcontentimaging #HCS #drugscreening